Study of Ixekizumab in Healthy Participants

Healthy Clinical Trial

Official title:

A Randomized Study to Investigate Injection-Site Pain Following Subcutaneous Injections of 2 Ixekizumab Test Formulations Compared to the Commercial Formulation Using a Pre-filled Syringe in Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03848403
• Other study ID #: 17139
• Secondary ID: I1F-MC-RHCS
• Status: Terminated
• Phase: Phase 1
• Start date: January 29, 2019
• Est. completion date: July 18, 2019

Study information

• Verified date: November 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions [ISRs]) will be collected.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: July 18, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Healthy male participants or female participants who agree not to get pregnant

• Are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant at increased risk by participating in the study

Exclusion Criteria:

• Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study

• Are allergic or hypersensitive to the study medicine

• Have dullness or loss of sensitivity on either side of your abdomen

• Have any condition that could affect pain perception from an injection

• Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study

• Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection

• Show evidence of active or latent tuberculosis (TB)

• Presence of significant neuropsychiatric disorder or a recent history of depression

• Have excessive tattoos or scars over the abdomen or other factors such as rash or excessive folds of skin that would interfere with injection site assessments

• Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator would pose an unacceptable risk to the participant if participating in the study

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Ixekizumab
Administered SC

Locations

Country	Name	City	State
United States	Covance	Dallas	Texas
United States	Covance Clinical Research Inc	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injection Pain Visual Analog Scale (VAS) Score	The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain = 30, moderate pain (>30 and =70), and severe pain (>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).	Day 1, 8, and 15: Immediately (within 1 minute) after injection